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I am looking into formulating anti-lice for syndet.most products I found labeled with Anti-lice only contains Neem extract, Madre de cacao and tea tree essential oil. I wonder if these ingredients would suffice😅

Thank you for sharing that information with me and giving me the correct terminology @Microformulation I'm incredibly new at all of this. And I knew regulations were handled by the FDA, but I didn't know that regulations of active ingredients were called monographs.

Once upon a time I was working towards being a research biologist in cellular biology. Searching for papers on various things that tickle my brain is still something I do quite often.

A 4% dimethicone(dimeticone) product that's left on for 15 minutes I believe is commonly used in the UK and NZ. I wonder if it would be worthwhile for someone to file to have it used similarly here?

@Soexcited Never feel that you have to apologize for not knowing something. This blog is at heart a learning tool and believing that you have learned it all often becomes a barrier to learning. So, don't apologize for being intellectually honest. If you approach this group with that in mind, you will gain a great deal of knowledge and many of the Professionals will weigh-in.

The best way to explain the monograph system is this. First, learn the FDA Definition of a Cosmetic; "FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance."

Notice that the definition has a strict "line in the sand", that being that a "Cosmetic" cannot address a disease state and cannot claim a physiological mechanism of action. These are "drug claims", not Cosmetic claims. (I know, you can produce examples of lines violating this restriction, they haven't been caught and I will only be endorsing textbook answers that address 100% compliance).

So, what happens when we make a product that has a drug claim? It either becomes an Over the Counter drug or it could even become a prescription product.

So if a product claims to help decrease dry skin and/or protect against it, it automatically shifts to being considered an otc? And the active ingredients that add those traits to the product have to be ones the FDA have listed for those conditions and in the percentages found on the monograph?

It sounds very much like the FDA's definition of supplements and how they must be taken by mouth since they're considered food. It's rather sad, because fat soluble substances like D3 would likely have a much better absorption rate at a lower dosage if they were applied inside the nostrils

But I have strayed very far off topic.I don't want to hijack this thread.I will continue researching FDA regulations. Thank you again

I was intrigued by this as Dimethicone is commonly used in Australian lice treatments as well. The lice treatment kits contain the dimethicone treatment solution and also include a very fine toothed comb. These treatments are all listed as "medical devices" on the Australian Register of Therapeutic Goods rather than as OTC or prescription drugs.

Moisturization is a Cosmetic claim. If you extrapolated that it treated eczema (and boy howdy, they do), it would become a drug claim.

Why are Cosmetics and Supplements different? Simply due to the fact that supplements are regulated by a different act and considered a separate product. They follow the Dietary Supplement Health and Education Act, (the DSEHA) not the Cosmetic Act.Remember this distinction since someday you will wrongly see someone say that they make any claims as long as they cite the DSEHA.

The LiceMD Pesticide Free is the Dimethicone product and they use careful wording. I have read that study before, but in that case, it was cited to show that dimethicone was less effective than Permethrin in the same time period. Remember, these studies are small and often they are selectively interpreted.

In the end, my best advice is to follow the letter of the law, not what "they" are doing. Remember, LiceMD has a Regulatory expert to consult with to mitigate liability.

markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.